(70 days)
The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
- Positioning fluoroscopy procedures
- Gastro-intestinal examinations
- Urogenital tract examinations
- Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
The DR 800 is not intended for mammography applications.
Agfa's DR 800 with Tomosynthesis a tomographic and fluoroscopic x-ray system (product codes IZF and JAA) intended to capture tomographic slices of the human body. The DR 800 is a floormounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital and wide dynamic range capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.
The Agfa DR 800 with Tomosynthesis underwent bench testing and software verification and validation to demonstrate substantial equivalence to its predicate devices, the GE Medical System's Discover XR656 with VolumeRAD (K132261) and Agfa's previous version of the DR 800 with MUSICA Dynamic (K180589). The primary focus of the testing for this submission was on the new Digital TomoSynthesis (DTS) software and its performance in generating tomographic slices.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technical & Acceptance Testing | All deviations or variances are documented, addressed in CR&T (Corrective and Remedial Actions) documentation, and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed. | Verification and validation testing confirmed the device meets performance, safety, usability, and security requirements. Pediatric indications were also taken into account. Results were verified and validated. Technical and acceptance testing was completed on the DR 800 with Tomosynthesis to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CR&T documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed. |
| Usability & Functionality Evaluation | The results of these tests fell within the acceptance criteria for the DR 800 X-ray system. | Usability and functionality evaluations were conducted with qualified independent radiographers and internal experts. The results of these tests fell within the acceptance criteria for the DR 800 X-ray system; therefore, the DR 800 supports a radiographic, fluoroscopic, and tomosynthesis workflow including dynamic and static imaging, continuous and rapid sequence exams, tomographic slices calibration, and positioning. |
| Image Quality Validation (Adults) | The reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria. DTS images were suitable for diagnosis. | Image Quality Validation testing was conducted using anthropomorphic phantoms and evaluated by qualified independent radiographers and internal experts. The image quality validation included testing a full range of applications for the DR 800 X-ray system with Tomosynthesis compared to reference images from the primary predicate GE Discovery XR656 with VolumeRAD (K132261) using anonymized adult phantoms. The test results indicated that the reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria and that the DR 800 with Tomosynthesis is capable of making DTS studies for adult patients. The test results showed MUSICA Digital TomoSynthesis (DTS) images were suitable for diagnosis for adult patients. |
| Image Quality Validation (Pediatric) | The reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria. Both 5x the dose and 10x the dose images were clinically sufficient and within the intended use, and DTS images were suitable for diagnosis for pediatric patients. | Image Quality Validation testing was conducted using anthropomorphic phantoms and evaluated by qualified independent radiographers and internal experts. The image quality validation included testing using anonymized pediatric phantoms. The pediatric phantom image quality validation testing analyzed five tomographic slices at 5x the dose and five tomographic slices at 10x the dose. Both the 5x the dose and 10x the dose images are clinically sufficient and within the intended use. The test results indicated that the reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria and that the DR 800 with Tomosynthesis is capable of making DTS studies for pediatric patients. The test results showed MUSICA Digital TomoSynthesis (DTS) images were suitable for diagnosis for pediatric patients. |
| Software Risk Assessment | No risks identified in the Not Acceptable Region. The device is assumed to be safe, and the benefits of the device outweigh the residual risk. | During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field. For the NX4.x.21 (NX Mentor) there are a total of 322 risks in the broadly acceptable region and 27 risks in the ALARP (As Low As Reasonably Practicable) region with only eight of these risks identified. Zero risks were identified in the Not Acceptable Region. |
| Electrical Safety & EMC Testing | Compliance with various IEC 60601 standards and FDA Subchapter J. | The DR 800 with Tomosynthesis is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 - 1020.32. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54 was confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical count of cases/images. The testing involved "anthropomorphic phantoms" for image quality evaluation, including both adult and pediatric phantoms. The pediatric phantom testing analyzed "five tomographic slices at 5x the dose and five tomographic slices at 10x the dose."
- Data Provenance: The data provenance is from bench testing using anonymized anthropomorphic phantoms. This indicates that the data is prospective in the sense that the phantoms were specifically used for this testing, but it is not from human patients. The country of origin of the data is not specified, but the manufacturer is Agfa N.V. (Belgium).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: "Qualified independent radiographers and internal experts" were used for usability, functionality, and image quality evaluations. The exact number of each group is not specified.
- Qualifications of Experts: They are described as "qualified independent radiographers and internal experts" and "qualified radiologists" (in the "Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence" section). Specific details like years of experience or subspecialty are not provided.
4. Adjudication Method for the Test Set
- The document implies that the "qualified independent radiographers and internal experts" evaluated the images and that the results "fell within the acceptance criteria" or "passed the acceptance criteria," suggesting a consensus or individual assessment against predefined criteria. However, a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC comparative effectiveness study was done. The study design described is a bench test comparison of the device against a predicate device's reference images using phantoms, with evaluation by human experts, rather than an assessment of human reader performance with or without AI assistance. The device itself is an imaging system, not an AI-powered diagnostic tool for interpretation assistance in the sense of comparing human performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone evaluation of the algorithm's output was done, as part of the image quality validation. The "reconstruction software of the image processing for Digital TomoSynthesis (DTS)" was evaluated to ensure the generated tomographic images were suitable for diagnosis. This is an assessment of the algorithm's output (the tomographic slices) without direct human intervention in the image generation process, beyond setting up the acquisition parameters.
7. The Type of Ground Truth Used
- The ground truth for the image quality evaluation was based on comparison to reference images from the primary predicate device (GE Discovery XR656 with VolumeRAD - K132261) using anthropomorphic phantoms, and expert assessment by "qualified independent radiographers and internal experts" confirming the images were "suitable for diagnosis" and "clinically sufficient." It is not pathology, or outcomes data.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for the training set for the MUSICA DTS software. It mentions that "The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with MUSICA Dynamic (K180589) and other devices in Agfa's radiography portfolio today... The addition of the tomographic image processing is similar to the predicate device (K132261)." This suggests leveraging existing, previously trained algorithms or development methodologies, rather than describing a specific new training dataset for this submission.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the document. As noted above, the submission emphasizes similarity to existing, cleared technologies, rather than detailing the unique training of a novel algorithm from scratch.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.